Hip fixation with load-controlled dynamization

ABSTRACT

System, including methods and apparatus, for hip fixation with load-controlled dynamization. In exemplary embodiments, the system may comprise a fixation element, such as a screw, configured to be placed into a proximal femur of a subject, with a leading end of the fixation element anchored in a head of the proximal femur. The system also may comprise a stop member configured to be connected (e.g., via a nail or plate) to the proximal femur. The system further may comprise a deformable member configured to be irreversibly deformed by compressive force exerted on at least a portion of the deformable member by the fixation element and the stop member in response to a load applied to the proximal femur by the subject, such that the fixation element and the stop member move relative to one another parallel to a long axis of the fixation element.

CROSS-REFERENCES TO PRIORITY APPLICATIONS

This application is a continuation-in-part of the following U.S. patentapplications: U.S. patent application Ser. No. 14/565,105, filed Dec. 9,2014; U.S. patent application Ser. No. 14/565,116, filed Dec. 9, 2014;U.S. patent application Ser. No. 14/566,350, filed Dec. 10, 2014; andU.S. patent application Ser. No. 14/706,922, filed May 7, 2015.

U.S. patent application Ser. No. 14/565,105, in turn, is based upon andclaims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional PatentApplication Ser. No. 61/913,593, filed Dec. 9, 2013.

U.S. patent application Ser. No. 14/565,116, in turn, is based upon andclaims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional PatentApplication Ser. No. 61/913,611, filed Dec. 9, 2013.

U.S. patent application Ser. No. 14/566,350, in turn, is acontinuation-in-part of U.S. patent application Ser. No. 14/565,105 andU.S. patent application Ser. No. 14/565,116, with priority claims aslisted above, and is based upon and claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/914,180, filedDec. 10, 2013.

U.S. patent application Ser. No. 14/706,922, in turn, is based upon andclaims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional PatentApplication Ser. No. 61/989,662, filed May 7, 2014.

Each of these priority patent applications is incorporated herein byreference in its entirety for all purposes.

INTRODUCTION

The hip joint is a synovial joint formed by articulation of the head ofthe femur (the femoral head) with the acetabulum of the pelvis. The hipjoint(s) supports the weight of the body when a person is standing,walking, or running, among others.

Trauma to the femur can fracture the femur near the hip joint. Dependingon the position and severity of fracture, the femoral head may bereplaced with a prosthesis, or the femur may be stabilized with animplanted fixation system to stabilize the femoral head while the femurheals. The fixation system may include a plate or a nail, among others.

Components of the fixation system may be freely slidable or fixedrigidly relative to one another, to respectively allow or preventintra-femoral movement at the fracture site. However, neither approachmay be optimal. An improved hip fixation system is needed.

SUMMARY

The present disclosure provides a system, including methods andapparatus, for hip fixation with load-controlled dynamization. Inexemplary embodiments, the system may comprise a fixation element, suchas a screw, configured to be placed into a proximal femur of a subject,with a leading end of the fixation element anchored in a head of theproximal femur. The system also may comprise a stop member configured tobe connected (e.g., via a nail or plate) to the proximal femur. Thesystem further may comprise a deformable member configured to beirreversibly deformed by compressive force exerted on at least a portionof the deformable member by the fixation element and the stop member inresponse to a load applied to the proximal femur by the subject, suchthat the fixation element and the stop member move relative to oneanother parallel to a long axis of the fixation element.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front, partially sectional view of selected aspects of anexemplary hip fixation system installed in a fractured femur of asubject and configured for load-controlled dynamization throughdeformation of a deformable region of the system, in accordance withaspects of the present disclosure.

FIG. 2 is a pair of partially sectional, fragmentary views of thefixation system of FIG. 1, taken generally around the region indicatedat “2” in FIG. 1 and showing movement of components of the fixationsystem relative to one another, and associated movement of portions ofthe femur relative to one another, in response to a deforming loadapplied to the fixation system by the subject (compare panels A and B),to bring edges of a fracture into contact with one another.

FIG. 3 is a view of an exemplary deformable spacer element to provide adeformable region for any of the hip fixation systems of the presentdisclosure, with the element having a cellular structure formed by 3-Dprinting to render the element crushable by plastic deformation toreduce the volume occupied by the element, in accordance with aspects ofthe present disclosure.

FIG. 4 is a view of another exemplary deformable spacer element toprovide a deformable region for any of the hip fixation systems of thepresent disclosure, with the element being formed by a foam, inaccordance with aspects of the present disclosure.

FIG. 5 is a view of still another exemplary deformable spacer element toprovide a deformable region for any of the hip fixation systems of thepresent disclosure, with the element being formed by a polymer, inaccordance with aspects of the present disclosure.

FIG. 6 is a partially sectional view of another exemplary embodiment ofa hip fixation system with load-controlled dynamization, with the systemattached to a fractured femur and including a support member structuredas a nail and also including a fixation element extending through thenail, and with the fixation element having a deformable regionconfigured for plastic deformation by deforming contact with a set screwinside the nail in response to a load applied to the system by asubject, in accordance with aspects of the present disclosure.

FIG. 7 is a partially sectional and exploded view of yet anotherexemplary embodiment of a hip fixation system with load-controlleddynamization, with the system attached to a fractured femur andincluding a support member structured as a side plate having a barrelportion that contains a deformable member and also including a fixationelement received in the barrel portion and configured to apply adeforming force to the deformable member in cooperation with a stopmember of the system, in accordance with aspects of the presentdisclosure.

FIG. 8 is a partially sectional view of still another exemplaryembodiment of a hip fixation system with load-controlled dynamizationvia plastic deformation of a deformable member of the system, with thesystem attached to a fractured femur and including a plurality ofdeformable spacer elements each capable of plastic deformation inresponse to a load applied to the system, in accordance with aspects ofthe present disclosure.

FIG. 9 is a front view of still yet another exemplary embodiment of ahip fixation system with load-controlled dynamization via plasticdeformation of a deformable member of the system, with the systemattached to a fractured femur and including a support member mounted tothe lateral cortex of the femur and also including a fixation elementanchored in the femoral head and attached to a deformable member that isdeformed by contact with a stop member of the support member, inaccordance with aspects of the present disclosure.

FIG. 10 is a side view of the hip fixation system of FIG. 9, takengenerally along line 10-10 of FIG. 9 in the absence of the femur.

FIG. 11 is a fragmentary front view of the hip fixation system of FIG.9, taken after deformation of the deformable member and associated axialmovement of the support member and the fixation element relative to oneanother.

FIG. 12 is a partially sectional and exploded view of an exemplaryembodiment of a hip fixation system with friction-limited dynamization,with the system including a support member in the form of a side platehaving an internally tapered barrel portion, with a fixation elementextending into the barrel portion and having a deformable trailingportion, and with the barrel portion providing an increasing resistanceto axial travel of the side plate and the fixation element relative toone another as the barrel portion moves toward the leading end of thefixation element, in accordance with aspects of the present disclosure.

FIG. 13 is a somewhat schematic sectional view of the side plate of FIG.12, taken as in FIG. 12 but with the internal taper of the barrelportion exaggerated.

FIG. 14 is a partially sectional and exploded view of an exemplaryembodiment of a hip fixation system having load-controlled dynamizationgoverned by a ratchet, in accordance with aspects of the presentdisclosure.

FIG. 15 is a partially sectional and exploded view of another exemplaryembodiment of a hip fixation system having load-controlled dynamizationgoverned by a ratchet, in accordance with aspects of the presentdisclosure.

FIG. 16 is a partially sectional view of a yet another exemplaryembodiment of a hip fixation system having load-controlled dynamizationgoverned by a ratchet, in accordance with aspects of the presentdisclosure.

DETAILED DESCRIPTION

The present disclosure provides a system, including methods andapparatus, for hip fixation with load-controlled dynamization. Inexemplary embodiments, the system may comprise a fixation element, suchas a screw, configured to be placed into a proximal femur of a subject,with a leading end of the fixation element anchored in a head of theproximal femur. The system also may comprise a stop member configured tobe connected (e.g., via a nail or plate) to the proximal femur. Thesystem further may comprise a deformable member configured to beirreversibly deformed by compressive force exerted on at least a portionof the deformable member by the fixation element and the stop member inresponse to a load applied to the proximal femur by the subject, suchthat the fixation element and the stop member move relative to oneanother parallel to a long axis of the fixation element.

The load-controlled dynamization disclosed herein may have variousadvantages over other hip fixation systems. The ability of systemcomponents to move relative to one another in a load-controlled mannerreduces the incidence of cutout of the fixation element through thefemoral head, relative to a system in which system components arerigidly attached to one another. Controlling and limiting movement ofsystem components reduces femoral shortening and establishes a limit forthe amount of femoral shortening that can occur, relative to a systemwhere system components are freely slidable relative to one another.

Further aspects of the present disclosure are described in the followingsections: (I) overview of an exemplary hip fixation system, (II) methodsof hip fixation, (III) composition of system components, (IV) kits, and(V) examples.

I. OVERVIEW OF AN EXEMPLARY HIP FIXATION SYSTEM

This section provides an overview of an exemplary hip fixation systemconfigured for load-controlled dynamization through deformation of adeformable region of the system; see FIGS. 1-5.

Load-controlled dynamization may permit post-surgical compression of afemoral fracture to accommodate settling of the fracture (e.g.,shortening of the femoral neck). “Load-controlled dynamization,” as usedherein, is any movement and/or change in position of portions of the hipfixation system relative to one another that is caused by a load appliedto the hip fixation system and/or the femur, typically by a subject intowhich the system has been installed. The dynamization may be“distance-limited,” which means that additional movement within thefixation system requires increasing force according to the degree ofmovement and/or change in position that the fixation system has alreadyundergone, optionally with a maximum distance of dynamization predefinedfor the system. Load-controlled dynamization of the hip fixation systemgenerally results in a corresponding load-controlled dynamization ofportions of the femur relative to each other, such as dynamization ofthe femoral head (a medial portion of the femur) and the femoralbody/shaft (a lateral portion of the femur) relative to one another.

FIG. 1 shows a front view of selected aspects of a hip fixation system50 attached to a femur 52 having at least one discontinuity, such as afracture 54 or a cut. Fracture 54 may include an intracapsular fracture(e.g., a neck fracture) and/or an extracapsular fracture (e.g., anintertrochanteric fracture).

System 50 may include at least one fixation element 56 (e.g., one, two,three, or more fixation elements), one or more support members 58 a, 58b operatively associated with the fixation element, a deformable member60, and a stop member 61. The deformable member may be capable ofdeformation that allows the fixation element and the stop member (and/orsupport member(s)) to move relative to one another, indicated by amotion arrow at 62, such that the femur is compressed at fracture 54.The deformation may occur after the system is installed in a subject, inresponse to a load 64 applied by the subject to the system and/or femur52. The amount of deformation that occurs may vary with the appliedload, within a load range that causes deformation. The deformable membermay undergo plastic (irreversible) deformation and/or elastic(reversible) deformation as the fixation element and the stopmember/support member(s) move relative to one another. Furthermore, theresistance to further movement may increase according to the extent towhich the deformable member has already been deformed, such that anincreasing load is required for progressive movement of the systemcomponents relative to one another. In some embodiments, the deformablemember may be omitted.

Fixation element 56 may change in length and/or axial position along itslong axis, in response to load 64 (e.g., a downward force) applied tothe fixation element via femur 52. The load may be applied by arecipient of the fixation system, also called a subject, generally usingat least a portion of the subject's weight. In other words, the load maybe applied post-surgery, such as when the subject stands, walks, orruns, among others. The maximum load applied by the subject to fixationelement 56 may determine the magnitude of the change in length and/oraxial position of the fixation element, optionally up to a load limitand/or within a load range (such as a predefined/particular load range).The change in length and/or axial position may be accompanied by motionof the femoral head and the femoral shaft relative to one another, whichmay apply compression to fracture 54 (or other discontinuity).

Fixation element 56 interchangeably may be termed a transverse member, afemoral head fastener, or a femoral head anchor. The fixation elementmay be configured to be implanted transversely to a long axis of femur52. The fixation element extends from a lateral portion 66 (also calleda body) of femur 52, through a femoral neck 68, and into a femoral head70 (forming a medial portion 71 of the femur). The fixation element maybe anchored to medial portion 71 and slidable with respect to lateralportion 66 of the femur. A long axis 72 defined by fixation element 56(and/or a shaft thereof) may have any suitable transverse orientationwith respect to the long axis of femur 52, such as forming an angle ofat least about 100 degrees, less than about 150 degrees, or acombination thereof, among others. In exemplary embodiments, thefixation element is oriented at about 120 to 145 degrees with respect tothe femoral long axis. Lateral portion 66 of the femur includes a shaft74 of the femur and may include at least part of greater trochanter 76and/or lesser trochanter 78.

Fixation element 56 may impose any suitable restrictions onintra-femoral motion. For example, the fixation element may restrictrotational motion of the femoral head relative to the femoral shaft,such as varus motion of the femoral head. Also, the fixation element maypermit limited motion of the femoral head relative to the femoral shaftin a direction parallel to long axis 72.

The fixation element may have a leading portion 82 (interchangeablytermed a spanning portion) disposed in femoral head 70, and a trailingportion 84 disposed at least partially in lateral portion 66 of thefemur. (The leading portion enters bone before the trailing portionduring installation.) One or both portions 82, 84 of the fixationelement may be anchored in the femur. More particularly, one or bothportions 82, 84 may include an anchoring structure 86, such as anexternal thread 88, that engages bone to restrict movement of thefixation element with respect to bone in both directions parallel tolong axis 72. Accordingly, the fixation element may be a screw, such asa lag screw, with a thread only on leading portion 82. The anchoringstructure may be formed integrally with a shaft 90 of the fixationelement or may be provided by a discrete component that is movablerelative to the shaft. Exemplary anchoring structures include anexternal thread, one or more barbs, one or more flanges (e.g., annularor helical flanges), at least one extendable pin (e.g., a talon), apivotably deployed retainer, or any combination thereof, among others.In some embodiments, trailing portion 84 of fixation element 56 does notinclude an anchoring structure. The fixation element may be cannulated,with a bore extending axially through the leading portion, the trailingportion, or both (e.g., through the entire length of the fixationelement.) In some embodiments, the fixation element may have a head nearor at the trailing end of the fixation element (e.g., see Example 3).

Fixation element 56 may be disposed completely in the femur or mayproject from the femur, such as projecting from a lateral side of thefemur as shown in FIG. 1. Generally, only a fraction, if any, of thefixation element projects from the femur, such as less than 10% or 5% bylength, among others.

The fixation element may extend into and/or through at least one supportmember 58 a or 58 b. For example, in the depicted embodiment, thefixation element extends through an opening 92 defined by inner supportmember 58 a and into an opening 94 defined by outer support member 58 b.Each opening 92, 94 may be a blind hole or a through-hole, among others.The fixation element may be slidably disposed with respect to at leastone support member (and/or stop member 61) to permit motion parallel tolong axis 72 as deformable member 60 deforms.

Fixation element 56 may be formed as only one piece or may be formed byan assembly of two or more discrete components/pieces that are placedinto the femur as a unit. In some embodiments, the fixation element maybe attachable to a compression screw via a trailing portion of thefixation element, after the fixation element has been placed into thefemur. The compression screw may be turned to adjust a compressionapplied to the femur at a fracture 54 (e.g., see Examples 2, 4, and 5).The compression screw may extend through an opening defined bydeformable member 60.

The fixation element may have any suitable shape. For example, thefixation element may have a circular cross section and/or may include acylindrical shaft. In some embodiments, the shaft may include opposingends and a lateral surface extending between the opposing ends. Thelateral surface may include at least one non-cylindrical region. Thenon-cylindrical region may be a flat region, such as one or morelongitudinal flats, or at least one trough 96, among others (e.g., seeExample 1). Deformable member 60 may or may not be attached to theshaft, such that the fixation element and the deformable member can beplaced into the femur as a unit. If attached, the deformable member maybe attached to a non-cylindrical surface region of the shaft.

The fixation element may have a driver engagement structure 98 to allowthe element to interface with a driver for advancement into bone. In thedepicted embodiment, driver engagement structure 98 is a transversenotch formed at the trailing end of the element. In other embodiments,the driver engagement structure may include external facets or a socket(e.g., a hex socket), among others.

Each of support members 58 a, 58 b may be operatively associated withfixation element 56 by installation into the femur. A pair ofmembers/components of a system that are “operatively associated” arepositioned to allow direct contact with one another, or are separated byone or more intervening, implanted members/components of the system thatcollectively extend from one member/component of the pair to the othermember/component of the pair. Each support member 58 a, 58 b (and/orstop member 61) may have a fixed position with respect to lateralportion 66 of the femur after installation.

Inner support member 58 a may be a nail 100 (interchangeably termed anintramedullary nail) disposed at least predominantly inside the femur.Nail 100 may extend longitudinally in the femur. The nail may be usedwithout outer support member 58 b, and outer support member 58 b may beused without the nail, or they may be used in combination as shown. Thenail may be attached to bone with one or more fasteners 102 that extendinto and/or through transverse openings of the nail. At least onefracture 54 or other discontinuity of the femur may be spanned by thenail.

The nail may have any suitable structure. Nail 100 may be linear ornonlinear (e.g., with a longitudinal bend of less than about 10degrees). The nail may have a leading end region that is smaller indiameter than a trailing end region thereof. The nail may or may not becannulated longitudinally.

Outer support member 58 b may be disposed at least partially outside thefemur, such as located on and/or attached to a lateral cortex 104(interchangeably termed a lateral side) of the femur. The outer supportmember may include a mounting portion 106 provided by a plate device(which may be a buttress plate or a side plate, among others). Themounting portion may define openings to receive one or more fasteners108, such as screws, to mount the support member on the femur (and/or toconnect support members to one another). Each fastener 108 may or maynot extend into nail 100. The outer support member also may or may notinclude a barrel portion that extends into the femur and receives atrailing portion of fixation element 56 (e.g., see Examples 2, 4, and5).

Outer support member 58 b may include or at least partially containdeformable member 60. The deformable member may or may not be discretefrom the fixation element, each support member, and the stop member(s).The deformable member may or may not be attached to the fixationelement, a support member, and/or the stop member. Accordingly, in someembodiments, the deformable member may be described as an insert and ormay or may not be removable from opening 94 of support member 58 b (oropening 92 of support member 58 a). Fixation element 56 may extend intoopening 94 (or opening 92) to allow the fixation element to applydeforming pressure to deformable member 60, such as to compress theelement, with or without direct contact between the fixation element andthe deformable member.

Deformable member 60 may have any suitable position relative to fixationelement 56, a support member 58 a or 58 b, and stop member 61. In someembodiments, the deformable member may be operatively disposed between ashaft of the fixation element and the stop member (and/or supportmember). For example, the deformable member may be attached to a sidesurface region of the shaft between opposing ends of the shaft, and atleast a portion of the deformable member may be disposed between theside surface region and a region of the stop member (e.g., see Example1). Alternatively, the deformable member may be located between atrailing portion of the shaft and the stop member, and optionallycoaxial to the shaft (and/or fixation element) (also see Examples 2 and3). In some embodiments, the deformable member may be attached to anon-cylindrical surface region of the shaft, between opposing ends ofthe shaft, such as located in a trough defined by the shaft (see Example1).

FIG. 2 shows a pair of fragmentary views of fixation system 50 of FIG. 1taken before (panel A) and after (panel B) permanent compression of atleast a portion of deformable member 60. The compression results inmovement of fixation element 56 and outer support member 58 b (includingstop member 61) relative to one another, and movement of lateral andmedial portions 66, 71 of the femur relative to one another (e.g.,closer to one another). However, to simplify the following discussion,fixation element 56 and medial portion 71 of the femur including thefemoral head are considered to be movable, while outer support member 58b, inner support member 58 a, stop member 61, and lateral portion 66 ofthe femur, including the femoral shaft, are considered to be stationary.

Panel A of FIG. 2 shows a gap 116 at fracture 54 between fracture edgesof lateral and medial portions 66, 71. Accordingly, load 64 applied tothe head of the femur is transmitted efficiently to fixation element 56,instead of being shared between the fixation element and abutted edgesof the fracture. As a result, the load produces compression ofdeformable member 60 in a direction parallel to the long axis of thefixation element. The compression is accompanied by correspondingmovement of fixation element 56 and outer support member 58 b (includingstop member 61) relative to one another, until the gap is closed(compare panels A and B) and the load is shared between the fixationelement and the abutted edges of the fracture, or until the load is nolonger sufficient to further compress the deformable member.Alternatively, if the fixation element is considered as stationary,outer support member 58 b (including stop member 61) (and inner supportmember 58 a) and lateral portion 66 of the femur travel inward, namely,medially and superiorly within the subject, in a direction parallel tothe long axis of the fixation element. The fixation element and supportmember(s)/stop member may be configured to undergo any suitable maximummovement relative to one another, such as at least about 1, 2, or 5millimeters, and/or up to about 10 millimeters, among others. In otherembodiments, relative movement as described above may be permitted andcontrolled by friction or a ratchet, among others (e.g., see Examples 4and 5). In some embodiments, movement of the fixation element and thesupport member(s)/stop member relative to one another may be configuredto occur selectively in only one of two opposite axial directionsparallel to the long axis of the fixation element and, optionally,without changing the orientation of the fixation element with respect tothe support member(s).

In some embodiments, the fixation element may have an integraldeformable member that allows the element to undergo a change in length.The length may be reduced by deforming, such as via plastic deformation,a selectively deformable region of the fixation element. The fixationelement may undergo any suitable change in length (or axial position),such as at least about 1, 2, or 5 millimeters, and/or up to about 10millimeters, among others. The deformable region may undergo acorresponding change in dimension.

Deformable member 60 may have any suitable structure and composition.The deformable member may have a plurality of voids that allow themember to be compressed. The deformable member may be formed of metal(such as stainless steel, titanium, etc.), a polymer, or the like. Thedeformable member may be compressible, which may reduce the volumeoccupied (e.g., reducing the volume of an imaginary envelope defined bythe periphery of the deformable member). The deformable member may becompressible parallel to a first axis without substantially increasing adimension of the deformable member transverse to the first axis. Thedeformable member may be irreversibly deformable/compressible (i.e.,plastically deformable) or reversibly deformable/compressible (e.g.,elastically deformable). Compression of the deformable member may“crush” at least a portion of the deformable region, which is anyirreversible compression. The deformable member may include a regular orrandom array of voids, and may have a cellular and/or porous structure.

The deformable member may be included in and/or at least partiallycontained by an inner support member, an outer support member, afixation element, or a stop member, among others. Accordingly, thedeformable member may be formed integrally with the support member,fixation element, or stop member, or may be inserted into, attached to,and/or formed on and/or in a support member, fixation element, or stopmember.

FIG. 3 shows an exemplary deformable member 60 for hip fixation system50. The deformable member may have a plurality of voids 120, which maygive the deformable member a honeycomb-like structure. The deformablemember may be formed by, for example, 3-D printing. The deformablemember may or may not define an opening 122 (e.g., a through-hole) toreceive a portion of the fixation element (such as a shaft region or ahead region thereof) and/or a portion of a compression screw thatattaches to the fixation element (e.g., see Examples 2 and 3).

FIG. 4 shows another exemplary deformable member 60 for hip fixationsystem 50. The deformable member may have a porous structure, such asproduced by a foam, for example, a metal foam (e.g., Duocel® foam).

FIG. 5 shows still another exemplary deformable member for the hipfixation system of FIG. 1. The deformable member may have a porousstructure formed by a polymer or a plasma spray.

In other embodiments, the deformable member may, for example, extendtransversely back and forth one or more times (e.g., to create a sinuousstructure), follow a helical path, or the like.

Stop member 61 may have any suitable structure and position. The stopmember may be formed integrally with a support member (e.g., supportmember 58 b; see FIG. 1 and Example 3) or may be formed separately fromthe support member and then attached thereto (e.g., see Examples 1 and2). The stop member may, for example, be attached to the support memberby threaded engagement. The stop member may be adjustably positionableparallel to the long axis of the fixation element (e.g., see Example 2)or parallel to the long axis of the support member (e.g., see Example1), among others. Alternatively, the stop member may be permanentlyfixed with respect to the support member. The stop member may bepositioned coaxially with the fixation element (e.g., see FIG. 1 andExample 2), or may be adjustably offset from the central long axis ofthe fixation element (see Example 1).

Any of the hip fixation systems of the present disclosure also mayinclude a compliant interface and/or a fixation element 56 that isreversibly flexible (e.g., elastic). The compliant interface (and/orflexible fixation element) may permit off-axis pivotal motion of thefixation element (and/or a region thereof) with respect to a supportmember (e.g., a nail or a plate) and/or with respect to the shaft of thefemur, to reversibly change the orientation of at least a portion of thefixation element. Further aspects of hip fixation systems with asuitable compliant interface and/or flexible fixation element aredisclosed in the patent applications listed above underCross-References, which are incorporated herein by reference.

II. METHODS OF HIP FIXATION

This section describes exemplary methods of hip fixation using any ofthe fixation systems disclosed herein. The method steps described inthis section may be performed in any suitable order and combination andmay be combined with any other steps, and performed with any suitabledevices and/or combination of device features, disclosed elsewhereherein, such as in Example 6.

A subject's femur to be fixed may be selected. The femur may have atleast one discontinuity, such as at least one fracture. The at least onefracture may include an intracapsular fracture and/or an extracapsularfracture. Accordingly, the at least one fracture may include at leastone fracture of the femoral body, the femoral neck, and/or the femoralhead. The at least one fracture of the femoral body may include anintertrochanteric fracture and/or a subtrochanteric fracture. Anintertrochanteric fracture involves the greater trochanter and/or thelesser trochanter and/or is disposed intermediate the trochanters. Asubtrochanteric fracture is a fracture that is distal to the lessertrochanter.

A fixation system for fixation of the femur may be selected. Thefixation system may include any combination of the elements and featuresdescribed above in Section I and/or elsewhere in the present disclosure,such as in Section V. The fixation system may include at least onefixation element, one or more support members, at least one stop member,and at least one deformable member. In some embodiments, such as in thecase of a femoral neck fracture, a plurality of fixation elements may beselected. A support member may provide a mounting portion for placementon the femur and/or a projecting portion for placement into the femur.The projecting portion may be a barrel portion. In some embodiments,fractures of the femoral neck may be fixed using a support member in theform of a buttress plate having a mounting portion but no projectingportion (e.g., no barrel portion), or without a support member on thefemur. In some embodiments, intertrochanteric fractures may be fixedusing a plate device having no projecting portion (e.g., no barrelportion), or without a plate device. The plate device may or may not befastened to the body (e.g., the lateral cortex) of the femur with one ormore fasteners (e.g., one or more fasteners that are each distinct fromthe fixation element).

At least one deformable member may be selected for the fixation system.Each deformable member may be provided by a set of interchangeabledeformable members each having a different deformable region. Thedeformable regions may differ in the deformability of a deformablematerial that forms each deformable region, in size, in shape, or thelike. Selection of a deformable member from the set may be based on atleast one characteristic of a recipient of the fixation system, such asthe recipient's weight, height, activity level, age, or any combinationthereof, among others.

The femur may be stabilized by implanting the fixation system. Thefixation element(s) may be placed in the femur, with the fixationelement extending from a body to a head of the femur. If a plurality offixation elements are placed in the femur, they may (or may not) beplaced parallel to one another. A plate device may be attached to alateral surface region of the femur and/or a nail may be placed in amedullary canal of the femur. Each fixation element may extend into (andthrough) the plate device and/or nail. A deformable member may beoperatively disposed in the fixation system. A stop member may beoperatively disposed in the fixation system.

A load may be applied to the fixation system via the femur, after thefixation system has been implanted. The load may be applied using theweight of the system recipient.

III. COMPOSITION OF SYSTEM COMPONENTS

Each system component may have any suitable composition. Each may beformed of any suitable biocompatible material(s) and/or bioresorbable(bioabsorbable) material(s). Illustrative biocompatible materials thatmay be suitable for a fixation element, a plate device, a nail, and/or adeformable member of the fixation system include (1) metal (for example,titanium or titanium alloy, cobalt-chrome alloy, stainless steel, etc.);(2) plastic (for example, ultra-high molecular weight polyethylene(UHMWPE), polymethylmethacrylate (PMMA), polytetrafluoroethylene (PTFE),polyetheretherketone (PEEK), and/or PMMA/polyhydroxyethylmethacrylate(PHEMA)); (3) bioresorbable material or polymer (for example, polymersof α-hydroxy carboxylic acids (e.g., polylactic acid (such as PLLA,PDLLA, and/or PDLA), polyglycolic acid, lactide/glycolide copolymers,etc.), polydioxanones, polycaprolactones, polytrimethylene carbonate,polyethylene oxide, poly-β-hydroxybutyrate, poly-β-hydroxypropionate,poly-δ-valerolactone, poly(hydroxyalkanoate)s of the PHB-PHV class,other bioresorbable polyesters, and/or natural polymers (such ascollagen or other polypeptides, polysaccharides (e.g., starch,cellulose, and/or chitosan), any copolymers thereof, etc.)); (4) bonematerial or bone-like material (e.g., bone chips, calcium phosphatecrystals (e.g., hydroxyapatite, carbonated apatite, etc.)); or (5) anycombination thereof.

The system components may be formed of the same or different materials.For example, each may be formed of metal, each may be formed of plastic,or one or more may be formed of metal and another one or more may beformed of plastic, among others.

IV. KITS

The hip fixation system may be provided as a system/kit including atleast one fixation element, at least one plate device, at least onenail, one or more fasteners to attach the plate device/nail to bone, atleast one deformable member, at least one stop member, or anycombination thereof. The system/kit may provide two or more differentchoices for at least one of the components. For example, the system/kitmay include two or more plate devices of different size and/or shape,two or more fixation elements of different size (e.g., different lengthsor diameters) and/or compressibility, and/or two or more interchangeabledeformable members (e.g., having a different compressibility, adifferent limit of compressibility, etc.).

V. EXAMPLES

The following examples describe selected aspects and embodiments of thepresent disclosure including exemplary hip fixation systems withload-controlled dynamization, and methods of installing the systems tofix a femur. The components, aspects, and features of the systems,devices, and methods described in each of these examples may be combinedwith one another and with the systems, devices, and methods describedelsewhere herein, in any suitable combination. These examples areintended for illustration and should not limit the entire scope of thepresent disclosure.

Example 1. Hip Fixation System with a Nail

This example describes another exemplary hip fixation system 140including a nail 100 (as a support member 58 a), and a fixation element56 attached to a deformable member 60; see FIG. 6.

Hip fixation system 140 may include any suitable combination of featuresdescribed above, such as in Section I for system 50 (e.g., see FIGS.1-5), and elsewhere in the present disclosure. However, system 140 maynot utilize an outer support member 58 b (compare FIGS. 1 and 6).

Fixation element 56 is pre-attached to a deformable member 60 that ispositioned for contact with a stop member 61. The stop member isattached to nail and is adjustably positionable along the long axis ofthe nail by turning at least a portion of the stop member, to advancethe stop member into an operative position that restricts rotation ofthe fixation element about its long axis and obstructs axial travel ofthe deformable member after the nail and fixation element have beenplaced into the femur. In the depicted embodiment, stop member 61 isstructured as a set screw 142. In other embodiments, stop member 61 maybe any advanceable and retractable member that attaches to the nail,such as by threaded engagement.

The deformable member may be located in a longitudinal trough 96 definedby a shaft of the fixation element and may extend any suitable distancealong the trough, such as along only a portion or along the entirelength of the trough (as shown here). The deformable member may beformed as a separate element that is mounted in trough 96 afterformation or may be formed in the trough such as by application of asolidifiable material (e.g., a plasma spray or a polymerizationsolution) to the trough.

Screw 142 is received in an axial opening 144 defined by nail 100 andattaches to the nail via threaded engagement. The position of screw 142along the long axis of the nail is adjustable by turning the screw.Screw 142 has a tip 146 configured be advanced into trough 96 afterfixation element 56 has been placed into bone. Tip 146 prevents rotationof the fixation element about long axis 72. Also, the tip obstructsaxial travel of deformable member 60. Contact between the tip anddeformable member 60 limits and controls axial motion 62 of the fixationelement and nail (including set screw 142) relative to one another.Deformation of deformable member 60 in response to load 64 allowslimited axial motion 62 for compression of fracture 54. The stop member,such as screw 142, may or may not deform part of deformable member 60 asthe screw is being advanced into trough 96 during system installation.

Example 2. Hip Fixation System with a Side Plate Having a Barrel Portion

This example describes an exemplary hip fixation system 160 including aside plate 162 (as a support member 58 b) having a barrel portion 164that extends into femur 52, and also including a deformable member 60disposed in barrel portion 164; see FIG. 7.

Hip fixation system 160 may include any suitable combination of featuresdescribed above, such as in Section I for system 50 (e.g., see FIGS.1-5), and elsewhere in the present disclosure (e.g., Example 1).However, system 160 may not utilize an inner support member 58 a(compare FIGS. 1, 6, and 7). System 160 may be suitable for fixation ofan intertrochanteric fracture 54, among others.

Side plate 162 (also called a plate device) may include a mountingportion 106 from which barrel portion 164 projects. The mounting portionmay be configured to be mounted on the proximal femur, such as mountedon a lateral surface region provided by lateral cortex 104. The mountingportion may define one or more openings to receive fasteners 108, suchas bone screws, that attach the mounting portion to the femur. Mountingportion 106 and barrel portion 164 may be formed integrally with oneanother, or may be formed separately and assembled with one anotherbefore or during placement of the barrel portion into the femur and/orplacement of the mounting portion onto the femur.

Barrel portion 164 is configured to be placed into the proximal femurfrom a lateral side thereof (e.g., after fixation element 56 is placedinto the femur from the lateral side). The barrel portion defines achannel 166 in which the trailing end of fixation element 56 isreceived. The channel may be sized according the shaft diameter of thefixation element, to allow the fixation element to slide axially but toprevent off-axis movement of the fixation element. Alternatively, sideplate 162 may be configured to permit changes to the orientation of thefixation element as described in U.S. patent application Ser. No.14/565,105, filed Dec. 9, 2014, which is incorporated herein byreference.

Fixation element 56 may define an axial bore 168 that extendslongitudinally through the fixation element. The bore allows thefixation element to be installed in the femur over a guide wire. Atrailing region of the bore may include an internal thread 170 forengagement by a compression screw 172. The compression screw provides anadjustable head for the fixation element.

Barrel portion 164 also may be attached to a stop member 61. The stopmember may be formed integrally with the barrel portion or may be formedseparately and then attached permanently or removably to the barrelportion. In the depicted embodiment, the stop member is a removableinsert 174 received in channel 166, before or after the barrel portionhas been placed over the trailing end of the fixation element. Insert174 may attach to barrel portion 164 via threaded engagement, indicatedat 176, between an external thread formed by the insert and an internalthread formed inside the barrel portion by channel 166. The insert (andstop member 61 more generally) may define an axial through-hole 178 toreceive the shaft of compression screw 172. The shaft of the compressionscrew also may extend through hole 122 of deformable member 60. A headof compression screw 172 may engage insert 174 (and stop member 61 moregenerally) after the compression screw has been attached to fixationelement 56, to urge the fixation element toward the head of thecompression screw as the compression screw is turned, to applycompression to the femur at fracture 54. The head of the compressionscrew may be received at least partially in a counterbore defined bythrough-hole 178.

A deformable member 60 may be disposed in channel 166 adjacent thetrailing end of fixation element 56, and between the fixation elementand stop member 61 (such as insert 174). The deformable member may bediscrete and separate with respect to the stop member (such as insert174), fixation element 56, or both. Alternatively, deformable member 60and insert 174 (or fixation element 56) may be attached to one anotherbefore each is placed in channel 166, such that deformable member 60 andinsert 174 (or fixation element 56) are installed as a unit. In anyevent, the insert (and stop member 61 more generally) prevents removalof deformable member 60 from the trailing end of the channel andprovides a barrier for travel of the deformable member and fixationelement. Furthermore, insert 174 can be manipulated (i.e., turned) toadjust the axial position of deformable member 60 along channel 166, tosandwich the deformable member between fixation element 56 and insert174. Alternatively, system 160 may be implanted such that deformablemember 60 is located between fixation element 56 and stop member 61, butis not in contact with both fixation element 56 and stop member 61 untilafter the system is fully implanted.

In embodiments where barrel portion 164 has an integrally formed and/orpermanently attached stop member 61, deformable member 60 may be loadedinto channel 166 of barrel portion 164 from the inner end thereof,before the barrel portion is placed into the femur.

Example 3. Hip Fixation Systems for Neck Fractures

This example describes exemplary hip fixation systems 180, 190 eachhaving a deformable member 60 and configured to fix femoral neckfractures; see FIGS. 8-11.

Hip fixation systems 180, 190 may include any suitable combination offeatures described above, such as in Section I for system 50 (e.g., seeFIGS. 1-5), and elsewhere in the present disclosure (e.g., see Example1). However, systems 180, 190 each may (or may not) include a pluralityof fixation elements 56, which may extend parallel to one another afterplacement into the femur. Each fixation element 56 may or may not becannulated. Each fixation element 56 may have a head 192 that engages alateral surface region of the femur, to block inward travel of thefixation element into the femur, such that the fixation element appliescompression to the femur at fracture 54 during installation. Systems180, 190 may include a support member 58 b in the form of a buttressplate that is mounted to a lateral cortex of the femur but that does notinclude a barrel portion extending into the femur (compare FIG. 7 withFIGS. 8 and 9). Systems 180, 190 may not utilize an inner support member58 a (compare FIG. 1 with FIGS. 8 and 9).

Support member 58 b may be attached to a plurality of stop members 61that obstruct outward travel of deformable members 60. For example, thestop members may be formed integrally with a buttress plate or may beformed separately and then attached permanently or removably to thebuttress plate.

FIG. 8 shows system 180 having a pair of deformable members 60 eachpositioned between an inner (bone-facing) surface of support member 58 band head 192 of the fixation element. Each deformable member 60 may (ormay not) be disposed at least partially in a recess 194 defined in theinner surface of the support member.

Fixation element 56 may have a trailing extension 196 projecting outwardfrom a flange forming head 192. Extension 196 extends through adeformable member 60 and is received in an opening 94 of support member58 b. Opening 94 may be contiguous with recess 194 and guides relativeaxial travel 62 of the fixation element and the support member relativeto one another as each deformable member 60 is compressed.

FIGS. 9-11 show system 190 having at least one fixation element 56containing a deformable member 60 in a longitudinal slot 200 defined bythe trailing portion of the fixation element. Axial bore 168 of thefixation element may extend through deformable member 60 to the trailingend of the fixation element, such that the fixation element iscannulated. Slot 200 divides a trailing portion of the fixation elementinto a pair of branches 202, with deformable member 60 disposed betweenthe branches. Support member 58 b may form a stop member 61 in the formof a stop bar that is received in slot 200, to engage and compressdeformable member 60. The support member defines an opening 206 adjacentthe stop bar to receive one of branches 202 of fixation element 56.

Example 4. Hip Fixation System with Friction-Limited Dynamization

This example describes an exemplary hip fixation system 220 including aside plate 162 having a barrel portion 164 and also including a fixationelement 56 that wedges into the barrel portion; see FIGS. 12 and 13.

Hip fixation system 220 may include any suitable combination of featuresdescribed above, such as in Section I for system 50 (e.g., see FIGS.1-5), and elsewhere in the present disclosure (e.g., see Example 2).However, system 220 may have a deformable region 222 that iscompressible radially (toward the central long axis of the fixationelement) but not compressible deformably parallel to long axis 72.

System 220 has a barrel portion 164 with a tapered channel 166 thatnarrows toward the outer, trailing end of the barrel portion (and towardmounting portion 106). The outer end of the channel may widen to form acounterbore 224.

System 220 has a fixation element 56 and compression screw 172 thatattach to one another as described above in Example 2, to applycompression to the femur during system installation. However, insert 174of Example 2 is replaced by a washer 226 that seats in counterbore 224and blocks inward travel of the head of compression screw 172 toward thefemoral head as compression is applied.

Fixation element 56 may define a plurality of axial slits 228 formed inthe wall of the fixation element to provide communication with a centralaxial bore 230. The slits separate the trailing portion into a pluralityof axial branches 232 each projecting away from the leading portion ofthe fixation element. Each axial branch 232 is deformable radiallytoward the central long axis of the fixation element. Radial deformationof the axial branches produces a taper in the diameter of the trailingportion of the fixation element, toward the trailing boundary thereof.Accordingly, since the inner diameter of the barrel portion also istapered, the inside wall of the barrel portion in combination withdeformable region 222 of the fixation element provide an increasingresistance to axial motion 62 of fixation element 56 and side plate 162relative to one another, as the trailing portion of the fixation elementis wedged into the barrel portion.

FIG. 13 shows barrel portion 164 with the internal taper of channel 166more readily visible.

Example 5. Hip Fixation Systems with a Ratchet to Govern Dynamization

This example describes exemplary hip fixation systems 250, 260, and 270each including a support member 58 b and a fixation element 56 thatcollectively form a ratchet 280; see FIGS. 14-16. The ratchet providesan incrementally increasing resistance to axial travel 62 of fixationelement 56 and the support member relative to one another.

Hip fixation systems 250, 260, and 270 each may include any suitablecombination of features described above, such as in Section I for system50 (e.g., see FIGS. 1-5), and elsewhere in the present disclosure (e.g.,see Examples 2-4). However, system 220 may not utilize an inner supportmember 58 a (compare FIGS. 1 and 14-16) and may have an elasticallydeformable region forming part of ratchet 280.

FIG. 14 shows system 250 including a side plate 162 having a barrelportion 164. Ratchet 280 may be formed by a series of teeth 282 definedin channel 166 by an inside wall of barrel portion 164, and at least onecatch 284 (interchangeably termed a detent or pawl) defined by fixationelement 56 on a shaft thereof. The catch is configured to be received inthe interdental spaces (the notches) formed between teeth 282. Catch 284may or may not be formed integrally with the shaft of the fixationelement. Teeth 282 may define a diameter of channel 166 that variesalong the channel to produce a series of minimum diameters alternatingwith a series of maximum diameters. The minimum diameters may decreasetoward the trailing end of the barrel portion, such that incrementalmotion of catch 284 toward the outer surface of side plate 162 past eachtooth 282 requires increasing force. Incremental motion of the catch inthe reverse direction is selectively restricted by the asymmetricalprofile of each tooth. In some embodiments, fixation element 56 maydefine one or more axial slits 286 that facilitate radial deformation ofthe fixation element near catch 284, to allow the catch to move radiallyinward as the catch moves between interdental spaces.

FIG. 15 shows system 260, which combines features of system 250 andsystem 220 (also see FIGS. 12 and 14). Ratchet 280 of system 260 isgenerally similar to that of system 250 except that teeth 282 are formedon the shaft of fixation element 56 and one or more catches 284 areformed by barrel portion 164 in channel 166. Fixation element 56 hasslits 228 that allow radial deformation of the trailing portion of thefixation element. Catches 284 may be formed integrally with orseparately from the barrel portion. The diameter of teeth 282 maydecrease toward the trailing end of fixation element 56, and/or thediameter of catches 284 may decrease toward the trailing end of channel166, such that tooth-by-tooth incremental axial motion 62 of thefixation element and side plate relative to one another requiresincreasing force.

FIG. 16 shows system 270 for fixation of neck fractures. The system mayinclude one or a plurality of fixation elements 56 that each form aratchet 280 with support member 58 b, which is structured as a buttressplate. The ratchet is created by a series of teeth 282 arranged along ashaft of fixation element, and a catch formed by support member 58 b.Here, catch 284 is created by an integral lip of an opening defined bythe buttress plate. The lip may be movable elastically with respect tothe main portion of the support member, with the aid of an elasticallydeformable region 290 of the support member. In other embodiments, catch284 may be formed by a discrete component(s) with respect to the mainportion of the support member.

Example 6. Selected Embodiments

This example describes selected embodiments of a hip fixation systemwith load-controlled dynamization and methods of hip fixation with thesystem.

1. A method of hip fixation with load-controlled dynamization, themethod comprising: (A) stabilizing a femur with a fixation systemincluding a femoral head fastener defining a long axis and extendingfrom a body to a head of a femur; and (B) applying a load to the femoralhead fastener via the femur to change a length of the fastener and/or anaxial position of the fastener on the long axis, via an irreversibledeformation of a deformable region of the fixation system.

2. The method of paragraph 1, wherein the femoral head fastener includesa movable region that moves a distance equal to the change when the loadis applied, wherein the fixation system includes a fixed region arrangedaxially outward of the movable region and remaining fixed when thechange occurs, and wherein the deformable region is disposedintermediate the movable region and the fixed region.

3. The method of paragraph 1 or paragraph 2, wherein the deformableregion is provided by the femoral head fastener.

4. The method of any of paragraphs 1 to 3, wherein the step of applyinga load reduces a length of the femoral head fastener.

5. The method of any of paragraphs 1 to 4, wherein the femoral headfastener includes a shaft that provides the deformable region.

6. The method of paragraph 5, wherein the shaft includes another regionthat is substantially resistant to deformation.

7. The method of paragraph 6, wherein the deformable region and theother region have at least substantially nonoverlapping axial extentsalong the femoral head fastener.

8. The method of paragraph 6, wherein the deformable region and theother region have overlapping axial extents along the femoral headfastener.

9. The method of any of paragraphs 1 to 8, wherein the femoral headfastener includes a leading element and a trailing element that arediscrete from each other.

10. The method of paragraph 9, wherein the step of stabilizing a femurincludes a step of adjusting a compression of a fractured region of thefemur by turning the trailing element relative to the leading element.

11. The method of any of paragraphs 1 to 10, wherein the step ofapplying a load irreversibly deforms a region of a plate device of thefixation system via pressure exerted directly or indirectly on theregion of the plate device by the femoral head fastener.

12. The method of paragraph 11, wherein the step of applying a loadirreversibly deforms a discrete insert of the plate device.

13. The method of any of paragraphs 1 to 12, wherein the step ofapplying a load irreversibly deforms a spacer element of the fixationsystem disposed between the femoral head fastener and a plate devicethat is attached to the femur.

14. The method of any of paragraphs 1 to 13, wherein the step ofstabilizing a femur arranges a nail of the fixation systemlongitudinally in the femur with the femoral head fastener extendingtransversely into and/or through the nail.

15. The method of any of paragraphs 1 to 14, wherein the step ofstabilizing a femur includes a step of placing a plurality of femoralhead fasteners parallel to one another.

16. The method of any of paragraphs 1 to 15, wherein the step ofstabilizing a femur arranges a barrel portion of the fixation systemsuch that the barrel portion extends into the femur, wherein the barrelportion defines a channel, and wherein the step of stabilizing a femurdisposes a portion of the femoral head fastener in the channel.

17. The method of any of paragraphs 1 to 16, wherein the femoral headfastener includes a first portion and a second portion, and wherein thestep of applying a load causes a region of the second portion to slidein a bore defined by the first portion to reduce a length of the femoralhead fastener.

18. The method of paragraph 17, wherein an insert is disposed in thebore and is deformed irreversibly by the step of applying a load.

19. The method of any of paragraphs 1 to 18, wherein the femoral headfastener includes two or more discrete pieces that are movable relativeto each other.

20. The method of paragraph 19, wherein at least a pair of the discretepieces are disposed in threaded engagement with each other.

21. The method of any of paragraphs 1 to 20, wherein the femoral headfastener includes a spanning element that spans a fracture in the femurand also includes a compression element (such as a compression screw),and wherein the step of stabilizing includes a step of connecting thespanning element to the compression element.

22. The method of paragraph 21, wherein at least a portion of thecompression element is disposed outward of the spanning element.

23. The method of any of paragraphs 1 to 22, wherein the femoral headfastener extends into one or more openings defined by a plate device, anail, or both a plate device and a nail, after the step of stabilizing afemur.

24. The method of any of paragraphs 1 to 23, wherein the step ofapplying a load decreases a volume of the deformable region defined by aperiphery of the deformable region.

25. The method of paragraph 24, wherein the deformable region has acellular and/or porous structure, optionally formed of metal.

26. A method of hip fixation with load-controlled dynamization, themethod comprising: stabilizing a femur with a fixation system includinga femoral head fastener defining a long axis and extending from a bodyto a head of a femur; wherein the fixation system includes a ratchetthat controls an axial position of the femoral head fastener on the longaxis.

27. The method of paragraph 26, wherein the ratchet permits incrementalaxial travel of the femoral head fastener in an outward axial direction.

28. The method of paragraph 26 or paragraph 27, wherein the ratchet is alinear ratchet.

29. The method of any of paragraphs 26 to 28, wherein the ratchet isformed by the femoral head fastener and a wall of an opening in whichthe fastener is partially disposed.

30. The method of paragraph 26 or paragraph 27, wherein the ratchet is arotary ratchet.

31. A method of hip fixation with load-controlled dynamization, themethod comprising: stabilizing a femur with a fixation system includinga femoral head fastener defining a long axis and extending from a bodyto a head of a femur; wherein the fixation system includes a barrelportion that provides an increasing resistance to outward axial travelof the femoral head fastener on the long axis by engagement of thebarrel portion with the femoral head fastener.

32. The method of paragraph 31, wherein the barrel portion defines atapered channel, further comprising a step of applying a load to thefemoral head fastener via the femur to wedge the femoral fastener in thetapered channel.

33. A method of hip fixation with load-controlled dynamization, themethod comprising: (A) stabilizing a femur with a fixation systemincluding a femoral head fastener defining a long axis and extendingfrom a body to a head of a femur; and (B) applying a load to the femoralhead fastener via the femur to change an axial position of the fasteneron the long axis, wherein the fixation system includes a support memberdisposed at least partially on the femur and having a pivotableconnection to the fastener, and wherein the pivotable connection definesa pivot axis that is transverse to the long axis of the femoral headfastener.

34. The method of paragraph 33, wherein movement at the pivotableconnection is governed by at least one deformable element.

35. The method of paragraph 34, wherein the at least one deformableelement is elastically deformable.

36. The method of paragraph 33 or paragraph 34, wherein the pivotableconnection is operatively connected to a plastically deformable memberthat governs a permitted pivotal range of motion at the pivotableconnection.

37. A system for hip fixation with load-controlled dynamization,comprising: a femoral head fastener defining a long axis and configuredto extend from a body to a head of a femur, wherein a load applied tothe femoral head fastener via the femur causes an irreversibledeformation of a deformable region of the fixation system and a changein a length and/or an axial position of the femoral head fastener on thelong axis.

38. A system for hip fixation with load-controlled dynamization,comprising: a femoral head fastener defining a long axis and configuredto extend from a body to a head of a femur; wherein the fixation systemincludes a ratchet that controls an axial position of the femoral headfastener on the long axis.

39. A system for hip fixation with load-controlled dynamization,comprising: a femoral head fastener defining a long axis and configuredto extend from a body to a head of a femur; and a barrel portion thatprovides an increasing resistance to outward axial travel of the femoralhead fastener on the long axis by engagement of the barrel portion withthe femoral head fastener.

40. A system for hip fixation with load-controlled dynamization,comprising: a femoral head fastener defining a long axis and configuredto extend from a body to a head of a femur; and a support memberconfigured to be disposed at least partially on the femur and having apivotable connection to the fastener, wherein the pivotable connectiondefines a pivot axis that is transverse to the long axis of the femoralhead fastener.

41. A system for hip fixation, comprising: (A) a fixation elementconfigured to be placed into a proximal femur of a subject such that aleading end of the fixation element is anchored in a head of theproximal femur and the fixation element extends from the head to alateral portion of the proximal femur; and a support member configuredto be connected to the proximal femur in a fixed relation to the lateralportion of the proximal femur and operatively associated with thefixation element; wherein the system includes a deformable regionconfigured to irreversibly deform in response to a load applied to thesystem by the subject, such that the fixation element and the supportmember move relative to one another parallel to a long axis of thefixation element.

42. The system of paragraph 41, wherein the fixation element includesthe deformable region, wherein the support member includes anintramedullary nail, and wherein the fixation element is configured toextend transversely through an opening defined by the intramedullarynail, further comprising a set screw received or receivable in theintramedullary nail and configured to engage the deformable region ofthe fixation element inside the intramedullary nail.

43. The system of paragraph 42, wherein the set screw also restrictsrotation of the fixation element about the long axis.

44. The system of paragraph 42, wherein the fixation element defines anaxial trough, and wherein the deformable region is formed by materiallocated in the axial trough.

45. The system of paragraph 41, wherein the support member is configuredto be mounted on a lateral cortex of the proximal femur and defines anopening to receive a region of the fixation element.

46. The system of paragraph 45, wherein the deformable region is locatedor locatable in the opening.

47. The system of paragraph 46, wherein the opening is a channel, andwherein the support member includes a barrel portion defining thechannel and configured to be received in the proximal femur.

48. The system of paragraph 47, wherein the deformable region isprovided by an insert placed into the channel of the barrel portion, andwherein the insert is discrete from the fixation element.

49. The system of system 48, further comprising a removable stop memberthat prevents removal of the insert from the barrel portion via an outerend of the channel.

50. The system of paragraph 49, wherein the stop member is configured tobe disposed in threaded engagement with the barrel portion.

51. The system of paragraph 41, wherein the fixation element is a firstfixation element, further comprising a second fixation elementconfigured to be placed into the same proximal femur such that a leadingend of the second fixation element is anchored in a head of the proximalfemur and the second fixation element extends from the head to a lateralportion of the proximal femur.

52. The system of paragraph 51, wherein each fixation element has ashaft and a head fixed to one another.

53. The system of paragraph 52, where each fixation element has anextension projecting from the head of the fixation element opposite theshaft, and wherein each extension is configured to move in an openingdefined by the support member when the fixation element and the supportmember move relative to one another parallel to a long axis of thefixation element.

54. The system of paragraph 41, wherein the fixation element is a screwhaving an external thread configured to anchor the screw to the head ofthe proximal femur.

55. The system of paragraph 41, wherein the deformable region is porousand/or cellular.

56. A method of hip fixation, the method comprising in any order:implanting a fixation system into a subject at least in part by (a)placing a fixation element into a proximal femur of the subject suchthat a leading end of the fixation element is anchored in a head of theproximal femur and the fixation element extends from the head to alateral portion of the proximal femur and (b) connecting a supportmember to the proximal femur in a fixed relation to the lateral portionof the proximal femur; wherein the steps of (a) and (b) are performed inany order relative to one another, wherein the step of implantingoperatively associates the fixation element and the support member withone another, and wherein the implanted fixation system includes adeformable region configured to irreversibly deform in response to aload applied to the system by the subject, such that the fixationelement and the support member move relative to one another parallel toa long axis of the fixation element.

57. The method of paragraph 56, wherein the support member includes anintramedullary nail, and wherein the fixation element is placed into theproximal femur after the intramedullary nail is connected to theproximal femur.

58. The method of paragraph 56, wherein the step of connecting a supportmember includes a step of attaching a support member on a lateral cortexof the proximal femur, wherein the attached support member defines anopening, and wherein the fixation element and the deformable region areeach located at least partially in the opening after the step ofimplanting.

59. The method of paragraph 58, wherein the opening is a channel,wherein the attached support member includes a barrel portion thatdefines the channel, and wherein the step of connecting a support memberincludes a step of inserting the barrel portion into the proximal femur.

60. The method of paragraph 56, wherein the step of placing includes astep of placing a pair of fixation elements into the head of theproximal femur, and wherein the step of implanting disposes a deformablemember between the support member and each fixation element.

61. A method of hip fixation, the method comprising in any order: (A)placing a fixation element into a proximal femur of a subject such thata leading end of the fixation element is anchored in a head of theproximal femur and the fixation element extends from a lateral portionof the proximal femur to the head of the proximal femur; (B) connectinga stop member to the lateral portion of the proximal femur; and (C)operatively disposing a deformable member between the fixation elementand the stop member such that the deformable member is irreversiblydeformable by compressive force exerted on at least a portion of thedeformable member by the fixation element and the stop member inresponse to a load applied to the proximal femur by the subject, suchthat the fixation element and the stop member move relative to oneanother parallel to a long axis of the fixation element.

62. A method of hip fixation, the method comprising in any order: (A)placing a nail longitudinally into a proximal femur of a subject; (B)placing a fixation element into the proximal femur such that a leadingend of the fixation element is anchored in a head of the proximal femurand the fixation element extends from a lateral portion of the proximalfemur, through a transverse opening of the nail, and to the head of theproximal femur, the fixation element including a shaft defining a longaxis, wherein the shaft of the fixation element is attached to adeformable member before the fixation element is placed into theproximal femur; and (C) manipulating a stop member that is attached tothe nail such that the stop member engages the deformable member insidethe nail and restricts rotation of the fixation element about the longaxis; wherein the deformable member is configured to be irreversiblydeformed by compressive force exerted on at least a portion of thedeformable member by the fixation element and the stop member inresponse to a load applied to the proximal femur by the subject, suchthat the fixation element and the stop member move relative to oneanother parallel to the long axis of the shaft.

63. A method of hip fixation, the method comprising in any order: (A)placing a fixation element into a proximal femur of a subject such thata leading end of the fixation element is anchored in a head of theproximal femur and the fixation element extends from a lateral portionof the proximal femur and to the head of the proximal femur; (B)attaching a side plate to a lateral cortex of the proximal femur, theside plate including a barrel portion that defines a channel thatextends into the proximal femur and receives a trailing portion of thefixation element; (C) attaching a stop member to the barrel portion; and(D) disposing a deformable member in the channel between the trailingportion of the fixation element and the stop member, wherein thedeformable member is configured to be irreversibly deformed in responseto a load applied to the system by the subject, such that the fixationelement and the barrel portion move relative to one another parallel tothe long axis.

The disclosure set forth above may encompass multiple distinctinventions with independent utility. Although each of these inventionshas been disclosed in its preferred form(s), the specific embodimentsthereof as disclosed and illustrated herein are not to be considered ina limiting sense, because numerous variations are possible. The subjectmatter of the inventions includes all novel and nonobvious combinationsand subcombinations of the various elements, features, functions, and/orproperties disclosed herein. The following claims particularly point outcertain combinations and subcombinations regarded as novel andnonobvious. Inventions embodied in other combinations andsubcombinations of features, functions, elements, and/or properties maybe claimed in applications claiming priority from this or a relatedapplication. Such claims, whether directed to a different invention orto the same invention, and whether broader, narrower, equal, ordifferent in scope to the original claims, also are regarded as includedwithin the subject matter of the inventions of the present disclosure.Further, ordinal indicators, such as first, second, or third, foridentified elements are used to distinguish between the elements, and donot indicate a particular position or order of such elements, unlessotherwise specifically stated.

I claim:
 1. A method of hip fixation, the method comprising in anyorder: placing a fixation element into a proximal femur of a subject,such that a leading end of the fixation element is anchored in a head ofthe proximal femur and such that the fixation element extends from alateral portion of the proximal femur to the head of the proximal femur;connecting a stop member to the proximal femur; and operativelydisposing a deformable member, such that the deformable member isconfigured to be plastically deformed by compressive force exerted on atleast a portion of the deformable member by the fixation element and thestop member in response to a load applied to the proximal femur by thesubject, wherein plastic deformation of the deformable member isaccompanied by movement of at least the leading end of the fixationelement and the stop member relative to one another parallel to a longaxis of the fixation element.
 2. The method of claim 1, wherein the stepof placing a fixation element includes a step of placing a fixationelement as a unit into the proximal femur, and wherein plasticdeformation of the deformable member is accompanied by movement of theentire fixation element and the stop member relative to one anotherparallel to the long axis of the fixation element.
 3. The method ofclaim 1, further comprising a step of disposing a nail in the proximalfemur, wherein the nail defines a transverse opening, and wherein thestep of placing a fixation element includes a step of placing a portionof the fixation element through the transverse opening after the step ofdisposing a nail.
 4. The method of claim 3, wherein the nail and thestop member are placed into the proximal femur as a unit.
 5. The methodof claim 3, wherein the step of operatively disposing a deformablemember includes a step of adjusting a position of the stop member withrespect to the nail and the fixation element after the step ofconnecting a stop member to the proximal femur.
 6. The method of claim1, further comprising a step of attaching a plate device to a lateralcortex of the proximal femur, and a step of placing a barrel portion ofthe plate device into the proximal femur, wherein a portion of thefixation element is disposed in the barrel portion after completion ofthe steps of attaching a plate device and placing a fixation element. 7.The method of claim 6, wherein the step of connecting a stop memberincludes a step of connecting a stop member to the proximal femur viathe plate device.
 8. The method of claim 7, wherein at least a portionof the stop member is disposed in the barrel portion of the plate deviceafter completion of the step of operatively disposing a deformablemember.
 9. The method of claim 1, wherein the step of placing a fixationelement includes a step of placing a plurality of fixation elements intothe proximal femur parallel to one another, and wherein the step ofoperatively disposing a deformable member includes a step of operativelydisposing a deformable member between each fixation element and a stopmember.
 10. A method of hip fixation, the method comprising: stabilizinga proximal femur of a subject by implanting a fixation system includinga fixation element defining a long axis and extending from a lateralportion of the proximal femur to a head of the proximal femur, thefixation system including a selectively deformable member and a stopmember; wherein the implanted fixation system is configured such thatthe subject applies a load to the fixation element via the proximalfemur to change a position of at least a portion of the fixation elementwith respect to the stop member by movement of the at least a portion ofthe fixation element and the stop member relative to one anotherparallel to the long axis as the deformable member deforms plastically.11. The method of claim 10, wherein the deformable member is provided bythe fixation element.
 12. The method of claim 11, wherein the fixationelement includes a leading element and a trailing element that arediscrete from each other and configured to move relative to one anotheras the deformable member deforms plastically.
 13. The method of claim10, wherein the step of stabilizing a proximal femur includes a step ofattaching a plate device to the lateral portion of the proximal femur,and wherein the deformable member is provided or held by the platedevice.
 14. The method of claim 10, wherein the step of stabilizing aproximal femur includes a step of operatively disposing the deformablemember between the fixation element and the stop member, and wherein thefixation element and the stop member are configured to apply compressiveforce to the deformable member in response to the load.
 15. The methodof claim 10, wherein the step of stabilizing a proximal femur includes astep of arranging a nail of the fixation system longitudinally in theproximal femur, and a step of placing a portion of the fixation elementthrough a transverse opening of the nail.
 16. A method of hip fixation,the method comprising: implanting a fixation system into a subject atleast in part by (a) placing a fixation element into a proximal femur ofthe subject, such that a leading end of the fixation element is anchoredin a head of the proximal femur and such that the fixation elementextends from a lateral portion of the proximal femur to the head of theproximal femur, and (b) connecting a plate device or a nail to theproximal femur in a fixed relation to the lateral portion of theproximal femur; wherein steps (a) and (b) are performed in any orderrelative to one another, wherein the step of implanting operativelyassociates the fixation element and the plate device or the nail withone another, and wherein the implanted fixation system includes adeformable member configured to plastically deform in response to a loadapplied to the fixation element by the proximal femur of the subject,such that the fixation element and the plate device or the nail moverelative to one another parallel to a long axis of the fixation element.17. The method of claim 16, wherein fixation system includes a nail, andwherein the fixation element extends transversely through the nail afterthe step of implanting.
 18. The method of claim 16, wherein the step ofconnecting a plate device or a nail includes a step of attaching a platedevice on a lateral cortex of the proximal femur, wherein the platedevice defines an opening, and wherein the fixation element and thedeformable member are each located at least partially in the openingafter the step of implanting.
 19. The method of claim 18, wherein theplate device includes a barrel portion, and wherein the step ofconnecting a plate device or a nail includes a step of inserting thebarrel portion into the proximal femur.
 20. The method of claim 16,wherein the step of placing a fixation element includes a step ofplacing a pair of fixation elements into the head of the proximal femur,and wherein the step of implanting operatively disposes a deformablemember between a plate device and each fixation element.